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Dysmenorrhea PrimaryNCT06761755

Taping and PMR Effects in Primary Dysmenorrhea

A study testing hot pack , K taping , Progressive muscle relaxation in people with Dysmenorrhea Primary, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is randomized controlled trial,The study conducted in two groups. Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation and Group… Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Dysmenorrhea Primary
What is being tested?
hot pack , K taping , Progressive muscle relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
23 Dec 2023to Feb 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • • Aged between 18-25 years
  • Unmarried female
  • Taking ≥4 points from Visual Analog Scale during menstrual cycle
  • Had moderate menstrual pain as measured by WaLLID score

Who cannot join

  • • Complaints of low back pain due to any other pathology, any skin infection, sensitive skin or allergic to Kinesio Tape.
  • PCOD, Uterine/ ovarian tumor, Acute/ chronic pelvic pathology like PID, endometriosis, spinal pathology and deformity
  • Endometrial polyp, having a pelvic infection, using an intrauterine device, having venous congestion in the internal genital organs.
  • Who take analgesic

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

imran NA amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Iqra Abdul ghafoor, PPDPT contact

03216414266

iqra.ghafoor@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • Ghurki hospital

    Lahore, Punjab Province, 54000

    Iqra Abdul ghafoor, PPDPT, 03324390125, iqra.ghafoor@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Combined Effects of Kinesiology Taping and Progressive Muscle Relaxation Technique on Pain, Anxiety and Body Awareness in Primary Dysmenorrhea

The study is randomized controlled trial,The study conducted in two groups. Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation and Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days. The total treatment duration will be 6 weeks. The rationale of this study is to provide empirical evidence regarding the efficacy and safety of kinesiology taping and progressive muscle relaxation. By investigating the potential benefits of this intervention, healthcare professionals can make informed decisions about incorporating K-taping and PMR in primary dysmenorhea. Focusing on the impact of kinesiology taping and progressive muscle relaxation on pain,anxiety, and body awareness aligns with a patient-centered approach to care. The goal is not only to reduce symptoms but also to enhance overall well-being and functional capacity

Read the detailed description

The literature gap of the study is that upto our knowledge, there is little or no evidence found in previous researches on the combined effects of kinesiology taping in combination with progressive muscle relaxation technique in primary dysmenorrhea.

Being tested
hot pack , K taping , Progressive muscle relaxation
Keywords
: Anxiety, dysmenorrhea, pain,
Medical subject headings
Anxiety Disorders, Dysmenorrhea, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hot pack , K taping , Progressive muscle relaxationOther

    Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation

    Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days

Study groups in NCT06761755
Study groupRoleWhat they receive
Group AActive comparatorHot pack+ kinesiology taping + progressive muscle relaxation technique Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation
Receives: Other: hot pack , K taping , Progressive muscle relaxation
Group BExperimentalhot pack + kinesiology taping Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days
Receives: Other: hot pack , K taping , Progressive muscle relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. numerical pain rating scale

    changes from base line NPRS is used to access the pain at 1st day or before the start of menstruation at the end score is calculated by dividing the obtained score by total 0 means no pain and 10 is maximum

    Measured: 1st day

  2. STAI tool (state triate anxiety inventory)

    changes in the baseline ,STAI tool to access the anxiety of the patient feels at the start of menstruation at the end the score is calculated by dividing the score by total 0 means no anxiety and 4 means maximum anxiety

    Measured: 1st day

  3. Body awareness questionaire

    Changes in the baseline, Body Awareness Questionnaire (Shields, Mallory \& Simon, 1989) acess the body awarenss during dysmenorhea , at the end the score is calcuted 0 means not true of me and 7 is the maximum true of me

    Measured: 1st day

Secondary outcomes (1)

  1. Wallid questionaire

    walid to access the Working ability, Location, Intensity (Wong-Baker) and Days of pain Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale.

    Measured: 1st day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start23 Dec 2023
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761755
Sponsor's protocol ID
REC/khushbu sohail
Status last verified
Jan 2025
First submitted
1 Jan 2025
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pazare S, Sawant L, Ingale S. The Effects of Kinesio Taping and Isometric Exercises on Pain in Primary Dysmenorrhea-A Comparative Study. Website: www ijpot com. 2019;13(4):4117

  • Bandara EMIA, Kularathne WNI, Brain K, Weerasekara I. Safety and efficacy of therapeutic taping in primary dysmenorrhea: a systematic review and meta-analysis. Sci Rep. 2022 May 3;12(1):7146. doi: 10.1038/s41598-022-11034-w.

    PubMed 35504906

  • Dogan H, Eroglu S, Akbayrak T. The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.

    PubMed 32379659

  • Mejias-Gil E, Garrido-Ardila EM, Montanero-Fernandez J, Jimenez-Palomares M, Rodriguez-Mansilla J, Gonzalez Lopez-Arza MV. Kinesio Taping vs. Auricular Acupressure for the Personalised Treatment of Primary Dysmenorrhoea: A Pilot Randomized Controlled Trial. J Pers Med. 2021 Aug 19;11(8):809. doi: 10.3390/jpm11080809.

    PubMed 34442453

  • Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.

    PubMed 33030880

  • Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.

    PubMed 32379680

  • Hamdy Nasr Abdelhalim E, Yehia Moustafa Sweelam M, Abd Elaziem Mohamed A, Gomaa Mohamed Amer F, El-Shabory ME-S, El-Hoda N. Effect of Progressive Muscle Relaxation Technique on Pain Intensity and FatigueAssociated with Primary Dysmenorrhea among Female Adolescents. Egyptian Journal of Health Care. 2023;14(1):486-500

  • Guruprasad P, Sharma U, Palekar T, Pimpri P. Immediate Effect of Yoga Postures v/s Physiotherapy Exercises Along with K-Taping on Pain in Dysmenorrhea. International Journal of Scientific Research in Science and Technology. 2019;6(2):487-94.

  • Unal A, Altug F, Erden A, Cavlak U, Senol H. Validity and reliability of the Body Awareness Questionnaire in patients with non-specific chronic low back pain. Acta Neurol Belg. 2021 Jun;121(3):701-705. doi: 10.1007/s13760-020-01399-y. Epub 2020 Jun 21.

    PubMed 32566989

  • Patel R, Patel AK, Gupta K. Premenstrual symptoms and general health among young adolescent girls: A correlational study. Perspectives on Coping Strategies for Menstrual and Premenstrual Distress: IGI Global; 2023. p. 1-12.

  • Sakpal S, Patil C. Efficacy of Chair Aerobics and Progressive Muscle Relaxation in Primary Dysmenorrhea. Journal of Coastal Life Medicine. 2023;11:1511-6.

  • George SA, Suresh G, Fathima P, Alias H. Effectiveness of physical activity and relaxation techniques in primary dysmenorrhea among college students. Int J Sci Res. 2019;8(11):531-3.

  • Kaur A, Ray G, Mitra M. Comparing the effectiveness of connective tissue mobilisation and kinesio-taping on females with primary dysmenorrhea. Indian Journal of Physiotherapy & Occupational Therapy. 2017;11:70-5

  • Temizkan S, BUDAK M. The Effects of Kinesiological Taping and Aerobic Exercise in Women with Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial. 2021.

  • Yildiz E, Acaroglu R. The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms in Students With Primary Dysmenorrhea: A Randomized Controlled Trial. Holist Nurs Pract. 2022 Sep-Oct 01;36(5):284-294. doi: 10.1097/HNP.0000000000000541.

    PubMed 35981113

Questions about this trial

What is this clinical trial studying?

A study testing hot pack , K taping , Progressive muscle relaxation in people with Dysmenorrhea Primary, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact imran NA amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

numerical pain rating scale (time frame: 1st day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06761755, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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